Non-interventional Studies

Non-interventional Studies (NIS) or post-marketing surveillance studies
are an indispensable instrument in pharmaceutical research and the medical device industry. Due to the
fact that clinical Phase I-IV trials with pharmaceuticals or medical devices provide us
with a limited number of data within a selected study population, we need
high-quality post-marketing surveillance studies to receive more
information about their use under real-life conditions which reflects
the medical routine practice. Hence reliable NIS data have a direct
impact on the evolution of pharmaceuticals and medical devices. However the budgets for these studies are usually very limited. This should no be the reason for poor quality. We are experts in running non-interventional studies. GCP-Service conducts NIS cost-efficiently without losing sight of quality requirements. We offer for your NIS:

GCP-Service conducts your NIS with your product in Europe. We work according to high quality standards based on following currently accepted principles:

Recommendations of the Association of Research-based Pharmaceutical
Companies (VFA) for the conduct of NIS (Jan, 2007)

Recommendations of the Federal Institute for Drugs and Medical Devices
(BfArM) and the Paul-Ehrlich-Institute (PEI) (draft from May 2007)

FSA codex (August 08)
- German Drug Law (AMG, paragraph 67.6)

Declaration of Helsinki where applicable
- Good Clinical Practice where applicable

For medical device manufacturer we run small studies with CE marked medical devices to confirm the CE mark. If you have a CE marked medical device but you have problems with selling your products we can support your to receive a tool number (German: Hilfsmittelnummer) to get reimbursement.